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研究以了解更多关于药物 VITRAKVI 在局部晚期或从开始扩散到身体其他部位的 TRK 融合癌患者常规使用期间的安全性和有效性的信息 (ON-TRK)

2026年10月21日 更新者：Bayer

Larotrectinib 治疗局部晚期或转移性 TRK 融合癌患者的前瞻性非干预研究

In this observational study researcher want to learn more about the effectiveness of drug VITRAKVI (generic name: larotrectinib) and how well the drug is tolerated during routine use in patients with TRK fusion cancer which is locally advanced or spread from the place where it started to other places in the body. TRK fusion cancer is a term used to describe a variety of common and rare cancers that are caused by a change to the NTRK (Neurotrophic Tyrosine Kinase) gene called a fusion. During this fusion, an NTRK gene joins together, or fuses, with a different gene. This joining results in the activation of certain proteins (TRK fusion proteins), which can cause cancer cells to multiply and form a tumor. VITRAKVI is an approved drug that blocks the action of the NTRK gene fusion. This study will enroll adult and paediatric patients suffering from a solid tumor with NTRK gene fusion for whom the decision to treat their disease with VITRAKVI has been made by their treating physicians. During the study, patients' medical information such as treatment information with VITRAKVI, other medication or treatments, changes in disease status and other health signs and symptoms will be collected within the normal medical care by the treating doctor. Participants will be observed over a period from 24 to 60 months.

研究概览

地位

主动，不招人

条件

干预/治疗

研究类型

观察性的

注册 (实际的)

54

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 中国
      • Many Locations、中国
        • Many Locations
  • 加拿大
      • Many Locations、加拿大
        • Many Locations
  • 卢森堡
      • Many Locations、卢森堡
        • Many Locations
  • 奥地利
      • Many Locations、奥地利
        • Many Locations
  • 德国
      • Many Locations、德国
        • Many Locations
  • 意大利
      • Many Locations、意大利
        • Many Locations
  • 比利时
      • Many Locations、比利时
        • Many Locations
  • 法国
      • Many Locations、法国
        • Many Locations
  • 瑞典
      • Many Locations、瑞典
        • Many Locations
  • 瑞士
      • Many Locations、瑞士
        • Many Locations
  • 美国
    • California
      • Los Angeles、California、美国、90095
        • UCLA - Mattel Children's Hospital
      • Los Angeles、California、美国、90027
        • California Research Inst.
      • Newport Beach、California、美国、82663
        • Hoag Memorial Hospital Presbyterian
      • Palo Alto、California、美国、94304
        • Stanford Univ Med Ctr. / Lucile Packard Children's Hosp
      • Santa Monica、California、美国、90404
        • Providence Health System - Southern California
      • Torrance、California、美国、90502
        • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
    • Connecticut
      • New Haven、Connecticut、美国、06520
        • Yale University
    • Florida
      • Miami、Florida、美国、33155
        • Nicklaus Children's Hospital
      • Miami、Florida、美国、33146
        • University of Miami
    • Indiana
      • Fort Wayne、Indiana、美国、46804
        • Fort Wayne Medical Oncology Hematology
    • Kansas
      • Wichita、Kansas、美国、67214
        • Cancer Center of Kansas
    • Maine
      • South Portland、Maine、美国、04106
        • Maine Health
    • Maryland
      • Baltimore、Maryland、美国、21205
        • Johns Hopkins / Sidney Kimmel Cancer Center
      • Frederick、Maryland、美国、21702
        • Frederick Health-James M Stockman Cancer Institute
    • Massachusetts
      • Boston、Massachusetts、美国、02111
        • Tufts / Neely Cancer Center
    • Michigan
      • Farmington Hills、Michigan、美国、48334
        • Detroit Clinical Research Center
      • Lansing、Michigan、美国、48912
        • Sparrow Cancer Center
    • Nevada
      • Las Vegas、Nevada、美国、89169
        • Nevada Cancer Research Foundation
    • New York
      • Buffalo、New York、美国、14210
        • Great Lakes Cancer Center
      • New York、New York、美国、10065
        • Memorial Sloan Kettering Children's Cancer Center
    • North Carolina
      • Greenville、North Carolina、美国、27834
        • East Carolina University / Vidant Health
    • Ohio
      • Youngstown、Ohio、美国、44501
        • Mercy Health Youngstown
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19104
        • Children's Hospital of Philadelphia
      • Pittsburgh、Pennsylvania、美国、15212
        • Allegheny Health Network
    • South Carolina
      • Charleston、South Carolina、美国、29425
        • Medical Univ. of South Carolina
    • Tennessee
      • Nashville、Tennessee、美国、37232
        • Vanderbilt University Medical Center
    • Texas
      • Dallas、Texas、美国、75390
        • UT Southwestern Medical Center / Children's Health
      • Houston、Texas、美国、77030
        • MD Anderson Cancer Center
    • Utah
      • Salt Lake City、Utah、美国、84112
        • Univ. of Utah / Huntsman Cancer Center
    • Washington
      • Seattle、Washington、美国、98105
        • Seattle Children's
    • West Virginia
      • Morgantown、West Virginia、美国、26506
        • West Virginia University
    • Wisconsin
      • La Crosse、Wisconsin、美国、54601
        • Gundersen Health System
      • Madison、Wisconsin、美国、53717
        • SSM Health Cancer Center - Dean Medical Group
  • 芬兰
      • Many Locations、芬兰
        • Many Locations
  • 西班牙
      • Many Locations、西班牙
        • Many Locations
  • 阿根廷
      • Many Locations、阿根廷
        • Many Locations
  • 韩国
      • Many Locations、韩国
        • Many Locations

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Adult and pediatric (from birth to 18-year-old) patients with a locally advanced or metastatic solid tumor harboring an NTRK gene fusion (detected by NGS (Next-Generation Sequencing), FISH (Fluorescent In Situ Hybridization), rt-PCR (Reverse Transcription Polymerase Chain Reaction) or other genomic testing able to detect NTRK gene fusion) assessed locally for whom a decision to treat with larotrectinib has been made before enrollment

描述

Inclusion Criteria:

  • Adult and pediatric (from birth to 18-year-old) patients
  • Patients with locally advanced or metastatic solid tumor harboring an NTRK gene fusion. NTRK (NTRK1, NTRK2, and NTRK3) gene fusions will be identified locally. Acceptable methods of detection of NTRK gene fusion include NGS, fluorescence in situ hybridization (FISH), reverse-transcription polymerase chain reaction (rt-PCR) or any other genomic testing able to detect NTRK gene fusion. If a pan-TRK IHC method is used, this result needs to be accompanied with the results using one of the other methods noted above.
  • Life expectancy of at least 3 months based on clinical judgement
  • Decision to treat with larotrectinib made by the treating physician prior to study enrollment
  • Patients can also be enrolled if the initial visit (larotrectinib start date) occurred within 2 months ±3 days prior to informed consent signed date
  • Signed informed consent form
  • For patients under legal age, signed assent by the patient (where applicable) and parental/legal guardian signed informed consent is required

Exclusion Criteria:

  • Any contraindications as listed in the local approved product information
  • Pregnancy
  • Participation in an investigational program with interventions outside of routine clinical practice
  • Prior treatment with larotrectinib or other kinase inhibitor with TRK inhibition
  • Patients with NTRK gene amplification or NTRK point mutation

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 观测模型：COHORT
  • 时间观点：PROSPECTIVE

队列和干预

团体/队列
干预/治疗
GI

adult patients with gastrointestinal (GI) cancer
药品：larotrectinib(Vitrakvi, BAY2757556)

In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol
H&N

adult patients with head and neck (H&N) cancer
药品：larotrectinib(Vitrakvi, BAY2757556)

In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol
STS

adult patients with soft tissue sarcoma (STS)
药品：larotrectinib(Vitrakvi, BAY2757556)

In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol
CNS

adult patients with primary central nervous system (CNS) cancer
药品：larotrectinib(Vitrakvi, BAY2757556)

In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol
Lung

adult patients with lung cancer
药品：larotrectinib(Vitrakvi, BAY2757556)

In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol
Melanoma

adult patients with melanoma
药品：larotrectinib(Vitrakvi, BAY2757556)

In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol
Pediatric

all pediatric patients regardless of tumor type will be enrolled under this cohort
药品：larotrectinib(Vitrakvi, BAY2757556)

In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol
other

patients with other tumor types
药品：larotrectinib(Vitrakvi, BAY2757556)

In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol

研究衡量的是什么？

主要结果指标

结果测量
大体时间
发生治疗中出现的不良事件 (TEAE) 的参与者人数
大体时间：最后一次给药后最多 30 天
最后一次给药后最多 30 天
TEAE 的严重程度
大体时间：最后一次给药后最多 30 天
最后一次给药后最多 30 天
TEAE 的严重性
大体时间：最后一次给药后最多 30 天
最后一次给药后最多 30 天
TEAE 的因果关系
大体时间：最后一次给药后最多 30 天
最后一次给药后最多 30 天
与拉罗替尼治疗相关的行动
大体时间：最后一次给药后最多 30 天
最后一次给药后最多 30 天
Larotrectinib 与 AE 之间的合理因果关系
大体时间：最后一次服药后最多 30 天
最后一次服药后最多 30 天

次要结果测量

结果测量
措施说明
大体时间
客观缓解率 (ORR)
大体时间：长达 8 年
长达 8 年
疾病控制率（DCR）
大体时间：长达 8 年
长达 8 年
缓解持续时间 (DOR)
大体时间：长达 8 年
长达 8 年
响应时间 (TTR)
大体时间：长达 8 年
长达 8 年
无进展生存期 (PFS)
大体时间：长达 8 年
长达 8 年
总生存期（OS）
大体时间：长达 8 年
长达 8 年
总剂量
大体时间：长达 8 年
长达 8 年
开始和结束剂量
大体时间：长达 8 年
长达 8 年
治疗期间调整剂量
大体时间：长达 8 年
长达 8 年
治疗持续时间 (DOT)
大体时间：长达 8 年
长达 8 年
按患者亚组划分的 ORR
大体时间：长达 8 年
长达 8 年
按患者亚组划分的 DCR
大体时间：长达 8 年
长达 8 年
按患者亚组划分的 DOR
大体时间：长达 8 年
长达 8 年
按患者亚组划分的 TTR
大体时间：长达 8 年
长达 8 年
按患者亚组划分的 PFS
大体时间：长达 8 年
长达 8 年
按患者亚组分类的 OS
大体时间：长达 8 年
长达 8 年
Number of patients with change in height and weight from baseline by visit, neurological abnormalities (normal/abnormal)
大体时间：Up to 8 years

for all patients
Up to 8 years
Number of patients with abnormal developmental milestones
大体时间：Up to 8 years

Pediatric cohort only
Up to 8 years
Number of patients with abnormal Tanner stage
大体时间：Up to 8 years

Pediatric cohort only
Up to 8 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Bayer

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年4月3日

初级完成 (估计的)

2029年12月31日

研究完成 (估计的)

2030年8月1日

研究注册日期

首次提交

2019年10月17日

首先提交符合 QC 标准的

2019年10月25日

首次发布 (实际的)

2019年10月29日

研究记录更新

最后更新发布 (实际的)

2026年10月22日

上次提交的符合 QC 标准的更新

2026年10月21日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 20324

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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